FDA WARNING_LETTER - Unlimited Water Processing Inc - November 11, 2014

On November 4-11, 2014, FDA inspected Unlimited Water Processing, Inc.'s bottled water facility, revealing serious deviations from 21 CFR Part 129 (Bottled Drinking Water Regulations) and 21 CFR Part 110 (Current Good Manufacturing Practice for foods). These render products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations include: * Failure to conduct E. coli follow-up testing for three production lots (6015414, 6016014, 6016214) that tested positive for total coliform, as required by 21 CFR 129.80(g)(1). The firm also failed to address shipping coliform-positive bottles exceeding limits (21 CFR 165.110(b)(2)(i)(A)). * Failure to analyze weekly production samples for total coliform for 17 weeks in 2014, violating 21 CFR 129.80(g)(1). * Failure to maintain records of physical inspections, maintenance, and performance of water treatment equipment (e.g., filter changes, pH calibration), as required by 21 CFR 129.80(a). * Failure